Efficacy of Aspirin Therapy After Desensitization on Chronic Rhinosinusitis With Nasal Polyps Patients With Asthma and Non-steroidal Anti-inflammatory Drug Exacerbated Respiratory Disease -A Randomized Clinical Trial.

Abstract

Non-steroidal anti-inflammatory drug (NSAID) exacerbated respiratory disease (N-ERD) is a chronic inflammatory condition typically involving hypersensitivity to NSAIDs, asthma, and/or chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP). N-ERD increases the risk for severe hypersensitivity reactions, recurring sinonasal surgeries, or the need for systemic corticosteroid treatment. Aspirin (ASA) treatment after desensitization (ATAD) is a treatment option for N-ERD. Desensitization to ASA is reached with increasing ASA doses over a few days, followed by a long-term treatment. This study evaluated the efficacy of ATAD with an ASA dose of 250 mg in adult CRSwNP patients with asthma and N-ERD. Forty-one CRSwNP patients with comorbid asthma and N-ERD were recruited for this randomized double-blind clinical trial. Twenty-six patients had successful ASA desensitization, were randomized into placebo and ASA arms, and continued to 11 months of daily ASA, with a target dose of 250 mg. The outcome measures, including Sino-Nasal Outcome Test 22 (SNOT-22), nasal polyp score (NPS), Asthma Control Test (ACT), and EPOS 2012 CRS clinical control assessment, were evaluated at control visits at 1, 5, 11, and 12 months after the start of the treatment. In the linear mixed effects model, p-values for the combined effect of group and time showed no difference between placebo and ATAD for SNOT-22, ACT, and NPS, with p-values 0.17, 0.45, and 0.18, respectively. Neither group showed significant improvement in the EPOS 2012 CRS control assessment. In conclusion, no significant clinical difference was observed between ATAD and placebo in the treatment of CRSwNP patients with asthma and N-ERD.